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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K052108
Device Name SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100
Applicant
Sein Electronics Co., Ltd.
1308 Morningside Park Dr.
Alpharetta,  GA  30022
Applicant Contact JAY MANSOUR
Correspondent
Sein Electronics Co., Ltd.
1308 Morningside Park Dr.
Alpharetta,  GA  30022
Correspondent Contact JAY MANSOUR
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Codes
CGA   DXN   JJX  
Date Received08/03/2005
Decision Date 12/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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